Phonation device for tracheotomy patients including a check valve and filtering means

ABSTRACT

A phonation and respiratory aid device for a tracheotomy patient comprising a tracheotomy cannula, a non-return valve for permitting inhalation flow only, the valve being distorted both axially and radially due to inhalation, a connecting means for connection to a source of fluid from a forced oxygenation device, the connecting means being upstream of the valve in the inhalation flow direction, and two filtering elements also upstream of the valve, the filtering elements including a Venturi tube.

TECHNICAL FIELD

The present invention relates to valves and respiratory aid deviceswhich are placed in position on patients having undergone a tracheotomy.

This operation, which consists in opening the trachea in order tore-establish respiration, is indicated in the case of serious disease ofthe larynx, such as an oedema of the glottis or, for example, a seriouschronic respiratory insufficiency by obstructive, restrictive or severemixed syndrome.

After the trachea has been opened, a cannula, called tracheotomycannula, is placed in position, through which the outside air canpenetrate, thus ensuring pulmonary ventilation and aspiration of thebronchial mucosities.

The implantation of a tracheotomy cannula in the trachea of a patientgenerally does not allow the passage of the inhaled air in the directionof the upper respiratory tracts whose task is to ensure functioning ofthe vocal chords to allow the patient fitted with the apparatus toexpress phonemes.

PRIOR ART

To allow patients, in whose trachea a tracheotomy cannula is implanted,to conserve the possibility of expressing phonemes, it has already beenproposed to dispose, at the outer end of the channel of the tracheotomycannula, a valve including a non-return flap valve allowing the inhaledflow of air to penetrate in the trachea, whilst the exhaled air isblocked by the non-return valve inside the trachea and is thus conductedand forced towards the patient's vocal chords, insofar as the type oftracheotomy cannula allows this. Such prior devices are for exampleillustrated in application DE-U-8,701,414 which proposes mounting,inside an adapting piece added to the end of the tracheotomy cannula, acurved rigid flap valve elastically pre-stressed in abutment against anannular seat. Such an embodiment is delicate to produce, due inparticular to the difficulty to adjust and maintain the curve andpre-stress of the flap valve at values allowing both normal respirationand phonation. Furthermore, such an embodiment does not allow connectionto a forced oxygenation installation without removing the adapting piececomprising the flap valve.

In certain cases, it so happens that the haematosis function oftracheotomized patients spontaneously proves to be insufficient, thisrequiring the connection on the cannula of a source of additional oxygenensuring forced oxygenation.

In such situations, the devices of the prior art have proved unsuitablefor ensuring both the function of phonation and the function of forcedoxygenation leading, in the case of connection of the oxygenationinstallation, to removing the non-return valve and replacing it by anadapter. The patient, who is then in a state of forced oxygenation, canno longer speak, which obviously presents a certain disadvantage for thepatient and in particular involves particularly negative psychologicalconsequences.

U.S. Pat. No. 3,683,931 is also known, which describes a rigid valveaxially mobile inside the channel of an adapter and maintained inelastic abutment via a helical spring. Such an embodiment is alsodelicate to produce and the adjustment of the elasticity of the spring,which determines the reliability of the device, proves difficult. It isprovided to connect the device to a source of fluid, of the nebulizertype, without forced oxygenation.

The object of the invention aims at producing a phonation andrespiratory aid device for a patient having undergone a tracheotomy, notpresenting the drawbacks of the prior art devices and enabling thepatient to conserve the use of speech, whilst having the possibility ofundergoing a forced oxygenation.

Another object of the invention aims at producing an oxygeno-phonationvalve including a non-return flap valve whose functioning isparticularly reliable and which may be replaced simply.

Another object of the invention is to propose a respiratory aid devicecomprising a tracheotomy cannula and an oxygeno-phonation valveensuring, in complete safety and for a long-lasting period, thefunctions of oxygenation and phonation.

SUMMARY OF THE INVENTION

The objects of the present invention are attained thanks to a phonationand respiratory aid device for a tracheotomized patient, comprising atracheotomy cannula tip defining a channel, a non-return valve forpreventing passage of the exhaled air flow and for allowing passage ofthe inhaled air flow, a support means for said flap valve disposeddownstream of a means for connection to a source of fluid with respectto the inhaled air flow, characterized in that:

the support means is interposed in the channel and comprises a supportface forming a transverse wall allowing air to flow through,

the flap valve is mounted, by a fixing means defining a fixing area,against said transverse wall and downstream of the latter with respectto the inhaled air flow, said flap valve being constituted by a flexiblematerial that can be distorted so as to allow, on the one hand, itsdistorsion both axially and radially from its fixing area under theeffect of the inhaled air flow and, on the other hand, it to bemaintained in sealed relationship against the transverse wall under theeffect of the exhaled air flow,

the connecting means is a connection grip provided in the tip andadapted for connection to a forced oxygenation appliance.

Various other characteristics will appear from the following descriptionwith reference to the accompanying drawings, which show, by way ofnon-limiting examples, embodiments of the object of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a view in perspective of the device according to theinvention.

FIG. 2 is a view of the device according to the invention, taken along alongitudinal section.

FIG. 3 is a view in section of the device according to the invention,taken along line III--III of FIG. 2.

FIG. 4 is a view taken along a transverse section made along line IV--IVof FIG. 2.

FIG. 1 shows a general view of a respiratory aid device adapted to beimplanted in the trachea of a patient and comprising a tip 1 on which ismounted a unit 2 for filtration of the air flow.

BEST MANNER OF IMPLEMENTING THE INVENTION

The examples represented in FIGS. 1 to 4, show tips 1 of tracheotomycannulae, as well as filtration units 2, which present cylindrical crosssections. It is obvious that the cross sections of these two elementsmay present other geometrical shapes and the cross sections may inparticular present square, diamond, hexagonal or rectangular shapeswithout departing from the scope of the invention.

The tip 1, represented in FIG. 2, is generally implanted on the patientvia a tracheotomy cannula 3 shown schematically in FIG. 2. The tip 1 ofthe tracheotomy cannula 3, which may be made of plastics material forexample, defines an inner channel 4 whose diameter is preferablysubstantially constant along the tip 1.

A grip 5 for connection to an annexed oxygenation device, is provided inthe tip 1 and comprises a tubular connection proper and a bore throughthe wall of the tip 1. The tubular connection is preferably radial andperpendicular to the principal axis of the channel 4.

The channel 4 preferably comprises at least one annular shoulder 6formed downstream of the connection grip 5 with respect to the inhaledflow of air, of which the direction is represented by arrow A. Theseinner shoulders 6 are used as members for positioning elements intendedto be positioned in the channel 4.

The respiratory aid device according to the invention comprises aphonation valve constituted by a support means 7 disposed in channel 4.The support means 7 is preferably a bush added and blocked in positionin the channel 4 of the cannula against the annular shoulder 6. The bushcomprises a transverse wall extending through the section of the channel4. The wall thus defined is permeable to the inhaled and exhaled airflow and is preferably constituted by a series of cross pieces 8constituting orifices for passage of the air flow. The cross pieces 8join in a substantially central zone constituted by a ring 9.

The thickness of the transverse wall of the support means 7, in thepresent case the bush, defines a downstream face 11 with respect to theinhaled air flow A, forming a support face for a non-return flap valve12 mounted in sealed relationship against face 11. The shape of thenon-return valve 12 is chosen such that it completely obstructs thechannel 4 and is maintained in sealed abutment, preferably by a clip 13engaged by force in the central part of the ring 9 and elasticallyblocked in the ring 9.

The non-return flap valve 12 is chosen to be made of a flexible, elasticmaterial, such as latex, siliconed or not, capable of presentingproperties of distorsion from the fixing area defined by the fixedconnection between the non-return valve 12 and the support means 7,namely the clip 13 and the ring 9. These properties of distorsioninclude a radial distorsion from the fixing area and axial, i.e. in thedirection of the inhaled air flow.

It must be considered that the support face of the bush advantageouslycomprises at least two crosspieces 8, but that other equivalent meansmay also be employed such as, for example a grating assembly constitutedby bars or an assembly provided with orifices of circular shape, forexample. It can also be envisaged to produce the support and fixing areaof the non-return valve on the bush in an eccentric area with respect toaxis x--x' of the tip 1, even in an area located on the outercircumference of the bush. Of course, it can also be envisaged, moreparticularly in the last case mentioned, to provide a plurality ofpoints of fixing of the non-return valve 12 on the bush 7.

FIG. 2 also shows that the non-return valve 12 is preferably constitutedby a series of undulations adapted to give it accentuated flexibilityand elasticity.

The end opposite that part of the tip 1 which is positioned on thetracheotomy cannula 3, is intended to receive a filtration unit 2 which,in the embodiments shown in FIGS. 1 and 3, is preferably constituted bytwo filtering elements 2a and 2b.

The filtration unit 2 comprises an adapting tip 14, of section virtuallyidentical to that of tip 1, in order to be able to be inserted by forceand in sealed manner inside the channel 4 and to be blocked in positiontherein by means, for example, of systems of the jaw type. The adaptingtip 14 extends by two diverging branches 2a and 2b which may be ofcylindrical section, with longitudinal axes perpendicular to the axisx'x' of the tip 1, so as to give the filtration unit 2 the general formof a "T". The join between the two diverging branches 2a, 2b and the tip14, is constituted by a transition zone 15 of which the cross section isof dimensions smaller than the cross section of each of the divergingbranches 2a, 2b, to constitute a Venturi tube. The filtration elementsare advantageously composed of filtering cartridges 16 introduced ineach of the branches 2a, 2b and coming into abutment against theshoulders of each of the branches 2a, 2b resulting from the reduction insection of the zone of join 15. It can also be envisaged to provide asystem for regulation of the Venturi effect with manual control.

It is obvious that, in place of a filtration unit 2 provided with twodiverging branches forming a "T", a filtration unit comprising onesingle branch located in line with tip 1, may also be envisaged. It isalso possible to produce a filtration unit comprising more than twofiltration cartridges 16.

During inhalation of the air flow effected by the patient, the inhaledair is firstly filtered inside the cartridges 16, then is accelerated bythe Venturi system formed by the reduction in section of the zone ofjoin 15, to exert a pressure on the non-return valve 12 which thendistorts radially and axially in the direction of the inhaled air flow Ain order to allow the air flow to penetrate in the patient's larynx.

Upon exhalation of the air flow, the non-return valve 12 is applied insealed manner against the support face of the bush and thus forms anobstacle to the passage of the air through the cannula 4, then enablingthe patient to use the air imprisoned in the trachea to vibrate his/hervocal chords. If the state of the patient requires a forced oxygenation,the oxygen penetrates through the connection grip 5 and radially deformsthe non-return valve 12, in the same manner as defined previously, andis then blocked inside the patient's larynx, enabling him to conservethe use of speech, even in a situation of forced oxygenation, theconnection grip 5 lying upstream of the non-return valve 12 with respectto the inhaled air.

It may also be envisaged to provide a second annular shoulder 6a locateddownstream of the annular shoulder 6 adapted to receive the supportmeans 7, in order to serve as seat for receiving a safety deviceconstituted by a separation wall 17 of the channel 4 capable ofpreventing passage of the non-return valve 12 in the patient's trachea.In fact, by reason of a failure of the fixing means 13, it may happenthat the non-return valve 12 be led, during inhalation, to penetrate inthe trachea. To that end, the separation wall 17 advantageously consistsin a disc rendered permeable to the air flow, by means of orificesprovided in its thickness. Permeability of the wall 17 may be obtainedby a crosspiece structure, similar to that described for the supportface of the support means 7, or may consist in a grating or perforatedstructure.

The device thus described enables a tracheotomized patient to conservethe use of his/her vocal chords, even in the case of forced oxygenation,thanks to the valve and to the oxygeno-phonation device proposed.Assembly of the non-return valve 12 on a support means 7 added insidethe channel 4 allows, if necessary, an easy and rapid change of thephonation valve.

The invention is not limited to the examples described and shown, asvarious modifications may be made thereto without departing from itsscope and, in particular, a plurality of non-return valves may bedisposed in the section of channel 4.

POSSIBILITY OF INDUSTRIAL APPLICATION

The invention finds a preferred application in the production of tips oftracheotomy cannulae connected to forced oxygenation appliances in orderto constitute oxygeno-phonation devices.

We claim:
 1. A phonation and respiratory aid device for a tracheotomizedpatient, comprising a tracheotomy cannula having a tip, means defining achannel in said tip, means including a non-return flap valve forpreventing passage of an exhaled air flow and for allowing passage of aninhaled air flow, connecting means for permitting connection of saidcannula to a source of fluid, support means for supporting said flapvalve, said support means disposed downstream of said connecting meanswith respect to the inhaled air flow, wherein:said support means isinterposed in said channel and comprises means including a support faceforming a transverse wall for allowing air to flow through; fixing meansdefining a fixing area for mounting said flap valve against saidtransverse wall and downstream of said support means with respect to theinhaled air flow, said flap valve comprising a flexible materialarranged to distort both axially and radially away from said fixing areaas a result of the inhaled air flow and to be maintained in sealedrelationship against said transverse wall as a result of the exhaled airflow, and wherein said connecting means is a connection grip provided insaid tip and said source of fluid to which the connection means isconnected is a forced oxygenation appliance.
 2. A device as claimed inclaim 1, wherein said support means comprises a bushing fixed in saidchannel.
 3. A device as claimed in claim 2, wherein said support facecomprises two support face crosspieces joined at a common zone, saidcommon zone forming said fixing area.
 4. A device as claimed in claim 3,wherein said fixing means is a fixing clip tightened between said flapvalve and said common zone of said crosspieces, thereby defining saidfixing area at a location substantially central to said channel and to asurface of said flap valve.
 5. A device as claimed in claim 1, furthercomprising a separation wall which is permeable to air flow, and isinterposed and fixed in said channel downstream of said flap valve withrespect to the inhaled air flow.
 6. A device as claimed in claim 5,wherein said separation wall comprises separation wall crosspieces.
 7. Adevice as claimed in claim 1, further comprising means including afiltering unit for filtering the inhaled air flow, the filtering unitbeing disposed upstream of said grip with respect to the inhaled airflow.
 8. A device as claimed in claim 7, wherein said filtering unitcomprises means including an adapting tip for insertion into saidchannel, and at least one filtration cartridge.
 9. A device as claimedin claim 8, wherein said adapting tip comprises a transition zoneforming a Venturi tube.
 10. A device as claimed in claim 8, wherein saidadapting tip is extended by two diverging branches, each branchcomprising a filtration cartridge.
 11. A device as claimed in claim 10,wherein a joint between said two diverging branches and said adaptingtip comprises a transition zone having a cross section which is smallerthan cross sections of said diverging branches to form a Venturi tube.